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The goal of this trial is to evaluate the effectiveness of an active case-finding (ACF) strategy for detecting pulmonary tuberculosis (PTB) among patients with chronic obstructive pulmonary disease (COPD) in primary care settings in Henan Province, China. It will also assess the epidemiological status of COPD-PTB comorbidity in this population and evaluate the feasibility of the ACF strategy in real-world primary care settings.
This is a stepped-wedge cluster randomized controlled trial. Specifically, the intervention group will receive the ACF strategy in Year 1, Year 2, and Year 3, while the control group will receive routine follow-up care in Year 1 and Year 2, and will transition to receive the ACF intervention in Year 3. All clusters will eventually receive the ACF intervention.
The main questions it aims to answer are:
Does the ACF strategy decrease the prevalence of PTB among COPD patients compared with routine passive case-finding? What are the current prevalence and epidemiological characteristics of COPD-PTB comorbidity in primary care settings in Henan Province?
Participants will:
Receive ACF screening during their routine COPD follow-up visits in the intervention phase.
Continue their usual COPD care as prescribed by their healthcare providers. If diagnosed with PTB through ACF screening, participants will be referred to designated hospitals for treatment in accordance with the national standardized tuberculosis treatment protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Intervention Group | Experimental | This cluster receives the intervention during Years 1, 2, and 3. |
|
| Delayed Intervention Group | Other | This cluster serves as a no-intervention control during Years 1 and 2, and then transitions to receive the same intervention during Year 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACF strategy | Other | An ACF strategy integrating computer-aided diagnosis and GeneXpert MTB/RIF testing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The prevalence of bacteriologically confirmed PTB | the third year |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis delay time | Diagnosis delay is defined as the number of days from the date of the first screening test (e.g., CAD-assisted chest imaging) or the first medical examination for respiratory symptoms (for passive case-finding) to the date of bacteriologically-confirmed PTB diagnosis (positive Xpert MTB/RIF result). | Up to 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D055985 | Latent Tuberculosis |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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In Year 1, Arm A receive the intervention while Arm B serves as control. In Year 2, Arm A continues with the intervention, Arm B remains control. In Year 3, both Arm A and Arm B receive the intervention.
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000085343 | Latent Infection |